News & Analysis as of

Medicare Part D Reimbursements

Quarles & Brady LLP

Part D Pharmacies Required to Enroll in Data Exchange Module to Help Drug Price Negotiation Cash Flow Issue

Quarles & Brady LLP on

On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more

Bass, Berry & Sims PLC

Wall Street and Industry React Favorably to CMS Medicare Advantage Rate Increase & Final Part C and D Rule for 2026

Bass, Berry & Sims PLC on

Two recent announcements from the Centers for Medicare & Medicaid Services (CMS) offer early indicators as to how the Trump administration, including CMS administrator Dr. Mehmet Oz, may approach the Medicare Advantage (MA)...more

ArentFox Schiff

The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need...

ArentFox Schiff on

Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

Mintz - Health Care Viewpoints

Mintz IRA Update — The First Anniversary of the Inflation Reduction Act: A Year in Review

August 16, 2023 marked the one-year anniversary of the enactment of the Inflation Reduction Act (“IRA”). The first 365 days since the IRA’s passage brought the implementation of a number of significant changes to the Medicare...more

American Conference Institute (ACI)

[Event] 21st Annual Rx Drug Pricing Boot Camp - May 4th - 5th, New York City, NY

The American Conference Institute is hosting the 21st Annual Rx Drug Pricing Boot Camp in New York. With both federal and state law makers engaging in greater scrutiny of prescription drug pricing, now is the time when...more

Mintz - Health Care Viewpoints

CMS Proposed Rule for Refunding Overpayments Would Align With False Claims Act “Knowledge” Standard

The Centers for Medicare & Medicaid Services (CMS) proposed a rule late last year to harmonize the standard it would apply for providers to identify and refund overpayments with the “knowledge” standard under the False Claims...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-19: OIG Warns That Proposed Drug Cost Subsidization Arrangement May Warrant Sanctions

On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more

King & Spalding

OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

King & Spalding on

On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more

ArentFox Schiff

What Should Pharma Companies Expect From the Biden Administration?

ArentFox Schiff on

With the change of administrations typically comes a flurry of activity across all government agencies, and the same can be expected with the official start of the Biden Administration now well underway. What should...more

Sheppard Mullin Richter & Hampton LLP

Medicare Part B Most Favored Nation Drug Pricing Model: New Rules, New Lawsuits, New Tweets

On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more

Latham & Watkins LLP

Drug Pricing and Payment Policy: Key 2018 Developments and Potential 2019 Changes and Challenges

Latham & Watkins LLP on

Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices. Key Points: ..In 2018, the Administration implemented and...more

BakerHostetler

Obstruction of a Medicare Audit Doesn’t Require Direct Obstruction of a Federal Agent

BakerHostetler on

A registered pharmacist, the owner of two Alabama pharmacies, pleaded guilty to obstructing a 2012 federal audit of Medicare claims and agreed to pay a $2.5 million penalty to the government. The submission of the false and...more

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